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NCT01600586 · ClinicalTrials.gov registry record · NA
A Clinical Trial of A Pacifier-Activated Music Player
A NA study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT01600586 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 100 participants.
The verdict
NCT01600586, a NA study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
Neonatal intensive care unit infants are at high risk for oromotor difficulties including poor coordination of sucking swallowing and breathing. These feeding difficulties often result in prolonged hospitalization, with increased physiologic stressors and poor growth. In preliminary studies, Pacifier Activated Lullaby (PAL) use showed potential increased oromotor skills and decreased length of hospitalization. The investigators propose to test the hypothesis that a week-long PAL intervention can improve feeding skills and decrease stress compared to standard of care parental interactions in infants in the late preterm period. The investigators also hypothesize that these improvements will result in shorter hospital stays and increased growth in the intervention group. Our study design is a prospective randomized controlled trial design of 94 infants (Post-conceptional ages 34-36 weeks). The 47 intervention-group infant/mother dads will receive a book library with one lullaby book and record her voice to the PAL, which the music therapist will then administer in 15-minute sessions for 5 consecutive days. The 47 participants in the control group will receive the same library but no recording will be made or PAL used. Outcomes measured will include time to full oral feeds, suck rate and efficiency, salivary cortisol levels before and after intervention, daily growth parameters and nutritional data, and hospital length of stay.
Interventions
- DEVICE Pacifier-Activated-Lullaby system (PAL).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01600586
The ClinicalTrials.gov registry entry for NCT01600586 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pacifier-Activated-Lullaby system (PAL). is the first listed.
NCT01600586 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01600586 about?
NCT01600586 is a clinical study titled "A Clinical Trial of A Pacifier-Activated Music Player". Neonatal intensive care unit infants are at high risk for oromotor difficulties including poor coordination of sucking swallowing and breathing. These feeding difficulties often result in prolonged hospitalization, with increased physiologic stressors and poor growth. In preliminary studies, Pacifie...
What is the current status of trial NCT01600586?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2012-04. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01600586?
The interventions under investigation include: Pacifier-Activated-Lullaby system (PAL). (DEVICE).
Who is sponsoring clinical trial NCT01600586?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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